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FDA 510(k)

PRESSURE MONITOR

K-Number: K842194 · 1984-08-27

ApplicantNorton Texas Medical Products
Decision Date1984-08-27
Product CodeDXS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PRESSURE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Norton Texas Medical Products. It received FDA 510(k) clearance on 1984-08-27 under 510(k) number K842194. The device is classified under product code DXS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRESSURE MONITOR?

PRESSURE MONITOR is a medical device that received FDA 510(k) clearance on 1984-08-27. The listed applicant is Norton Texas Medical Products. The 510(k) number is K842194.

When did PRESSURE MONITOR receive FDA 510(k) clearance?

PRESSURE MONITOR received FDA 510(k) clearance on 1984-08-27, under 510(k) number K842194.

Who is the listed applicant for PRESSURE MONITOR?

The FDA 510(k) record lists Norton Texas Medical Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRESSURE MONITOR?

The FDA product code for PRESSURE MONITOR is DXS.

Related Clinical Trials

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Related PubMed Literature

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMID: 40388896Accuracy and Safety of a Continuous Noninvasive Blood Pressure Monitor in Neonates.Neonatology ()

Other records listing Norton Texas Medical Products as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K843983MYOCARDIAL INSULATORK842992GRASSHOPPER - RETRACTORK832517CUSTOM KWIK SET AND/OR PAK

Related Devices (Code: DXS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K113235PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONSMedtronic, Inc.K944764VTI DISPOSABLE PRESSURE DISPLAY SETVascular Technology IncorporatedK912045TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYSTLifestream Int'L, Inc.K900797STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XRShiley, Inc.K873802PRESSURE BARRIER KIT CAT. NO. PBK-3American Omni Medical, Inc.K862836STOCKERT-SHILEY CAPS AND CAPS DUAL PRESSURE MODULEShiley, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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